FDA approved KarXT/Cobenfy (official announcement & super thread)

https://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia

“Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.”

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It’s no longer called KarXT

It’s called Cobenfy!

The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness and gastroesophageal reflux disease.

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It doesn’t sound like it has fewer side effects then. Interesting

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I just read on fda.gov Cobenfy (KarXt) was approved today, September 26th, 2024

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Those are some really shitty side effects but i’m hoping they’d be rare

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Twice daily pill :pill:

Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfy, to be available in late October, executives told CNBC.

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I cant take it because i have liver cancer, it says it cant be taken in reduced hepatic function

I wonder how people will respond to it, outside of trials.

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Looks like we will see over the next few months.

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We will have to see the testimonies of people living in the United States, starting at the end of October.

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By focusing on acetylcholine instead of dopamine, Cobenfy may reduce schizophrenia symptoms while avoiding common side effects like weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies mirroring real-world challenges, many patients stopped treatment within 18 months of starting it.

In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. “That’s a significant improvement over the 20-30% seen with older antipsychotic drugs,” he added.

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I had no idea only 6% stopped taking it. That’s much lower than I thought! Wow.

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Many people stopped taking it because it was not working well for them as well as how they felt. I think total withdrawals were over 30%.

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That’s interesting. Do you have any links to that?

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https://www.delveinsight.com/blog/bristol-myers-squibb-karxt-emergent-4-trial#:~:text=The%20overall%20discontinuation%20rate%20in%20the%20trial%20was,follow-up%2C%20and%20failure%20to%20adhere%20to%20protocol%20requirements.
This article mentions a 53% discontinuation rate in Emergent 4 trial.

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It will cost 1850 dollars, according to what I read in the New York Times https://www.nytimes.com/2024/09/26/health/fda-schizophrenia-drug.html

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Hmm sounds like wats normal for a med tbh but it doesn’t mention negative symptoms
… That’s interesting u know, tiredness and weakness etc.

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Yes, it says

The overall discontinuation rate in the trial was 53%, and the primary reasons for discontinuation included withdrawn consent, treatment-related adverse events, failure in follow-up, and failure to adhere to protocol requirements.

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Yes, it will cost $1,850 per month. I hope it will be covered by most insurance.

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Who will be writing the article for schizophrenia.com

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